Clinical Trial

Microbiome and Sarcopenia in Patients With Liver Cirrhosis

Recruiting
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Summary
Protein-energy malnutrition (PEM) occurs in 65-90% of patients with liver cirrhosis. Severity of malnutrition correlates with progression of liver disease and leads to sarcopenia in 30-70% of cirrhotic patients. Malnutrition and sarcopenia are associated with an increased risk of complications and mortality. In cirrhosis the gut microbiome is altered leading to increased gut permeability, bacterial translocation and inflammation. Since the microbiome is involved in nutrient uptake and metabolism, it is hypothesized that microbiome alterations contribute to sarcopenia. A prospective controlled cohort study to investigate the interrelation of microbiome changes and sarcopenia in cirrhosis will be conducted. Furthermore the effect of nutritional interventions on the microbiome in cirrhosis will be studied. From this study information on how the gut microbiome composition and sarcopenia are associated in cirrhosis and if modulation of the gut microbiome by nutritional interventions is feasible will be collected.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2017-03-14; most recent amendment 2024-10-07.
Status change: Not Yet Recruiting → Recruiting 2017-05-24
Trial Details
NCT Number NCT03080129
Lead Sponsor Medical University of Graz
Conditions Sarcopenia, Liver Cirrhosis
Enrollment 120 participants
Start Date 2017-04-11
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-09